The Sci­en­tif­ic Com­mit­tee on Health, Envi­ron­men­tal and Emerg­ing Risks (SCHEER) of the Euro­pean Com­mis­sion has recent­ly updat­ed its guide­lines for assess­ing the ben­e­fits and risks of phtha­lates in med­ical devices. The updat­ed guide­lines are not only applic­a­ble to phtha­lates but also to oth­er sub­stances that are car­cino­genic, muta­genic, tox­ic to repro­duc­tion (CMR), or endocrine-dis­rupt­ing (ED). 

Designed for stake­hold­ers such as man­u­fac­tur­ers, noti­fied bod­ies, and reg­u­la­to­ry bod­ies, the guide­lines pro­vide a method for jus­ti­fy­ing the pres­ence of phtha­lates clas­si­fied as CMR 1A or 1B, and/or ED in devices, parts, or mate­ri­als used at a per­cent­age above 0.1% by weight. These sub­stances are oth­er­wise pro­hib­it­ed from use in med­ical devices under the med­ical devices reg­u­la­tion (MDR). Addi­tion­al­ly, the guide­line offers a method for assess­ing poten­tial alter­na­tives to CMR/ ED phtha­lates in devices, includ­ing alter­na­tive mate­ri­als, designs, or med­ical treat­ments. The approach of these guide­lines may also be used for a ben­e­fit-risk analy­sis of oth­er CMR/ ED sub­stances present in med­ical devices.

It is impor­tant to note that noti­fied bod­ies require this method for ben­e­fit-risk assess­ment as a stan­dard for any sub­stance in a med­ical device. Not using it may lead to ques­tions regard­ing why it was not used. Med­ical device man­u­fac­tur­ers must jus­ti­fy their use of haz­ardous phtha­lates and oth­er CMR or ED chem­i­cals under the MDR. Addi­tion­al­ly, those sub­stances’ pres­ence above min­i­mal lev­els must be com­mu­ni­cat­ed using a label on the device itself and/or on the pack­ag­ing for each unit. The infor­ma­tion labelled should be sub­mit­ted using the EUDAMED device reg­is­tra­tion module. 

The guid­ance update also involves minor revi­sions to the exist­ing doc­u­ment, pri­mar­i­ly focus­ing on the advance­ments made over the past five years con­cern­ing the appli­ca­tion, expo­sure, and tox­i­col­o­gy of alter­na­tives to phtha­late plas­ti­cis­ers in med­ical devices. 

Source: Medtech Insight (an Infor­ma product)

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